NCT05514717

A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2

A Phase 1, First-in-Human, Dose Escalation and Expansion, Multicenter Study of XMT-2056 in Participants With Advanced/Recurrent Solid Tumors That Express HER2

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 162 (estimated)
• Sponsor: Mersana Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A Study of XMT-2056 in advanced/recurrent solid tumors that express HER2.

Detailed description

The first-in-human (FIH) study of XMT-2056 is a Phase 1, open-label study of XMT-2056 in previously treated patients with advanced/recurrent solid tumors expressing HER2. The XMT-2056 monotherapy trial will consist of dose escalation (DES) and expansion (EXP) parts. DES will be the dose-finding portion of the study to assess the safety and tolerability of XMT-2056 and determine the maximum tolerated dose (MTD) and/or Recommended Phase 2 Dose (RP2D). The RP2D will be determined based on the totality of the clinical data, including safety and preliminary anti-tumor effect, PK, and relevant biomarker data.

Conditions

• HER2-positive Breast Cancer
• HER2-positive Gastric Cancer
• HER2-positive Non-Small Cell Lung Cancer
• HER2-positive Colorectal Cancer
• HER2-positive Tumors
• HER2 Low Breast Cancer

Interventions

Type	Name	Description
DRUG	XMT-2056	XMT-2056 will be administered through a vein in your arm or port catheter (intravenously)

Timeline

• Start date: 2023-01-24
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2022-08-24
• Last updated: 2025-07-11

Locations

14 sites across 1 country: United States

Regulatory

• FDA-regulated drug study